Extended-Release RANCAD in the Patients With Stable Angina Pectoris

NCT02294942 | Completed Phase 3 DMC

• 1 other identifier: TSHRN1201
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 6

Brief Summary

A double-blind, randomized, placebo-controlled, parallel study to evaluate the effects of add-on RANCAD on exercise tolerance and angina frequency in patients with stable angina pectoris.

Conditions

Stable Angina Pectoris

Keywords

RNTA06; RANCAD

Outcome Measures

Primary Outcomes (1)

• ETT performing at last treatment visit (Week 12).

  To compare the change from baseline of ETT performing duration between add-on RANCAD and placebo at trough (12 hours after dosing) at Week 12.

  Week 12 (not including screening & follow-up period)

Study Arms (3)

RANCAD 500mg

EXPERIMENTAL

RANCAD 1 tab (500 mg) + Placebo 1 tab, twice daily.

Drug: RANCAD

RANCAD 1000mg

EXPERIMENTAL

RANCAD 2 tabs (500 mg), twice daily

Drug: RANCAD

Placebo

ACTIVE COMPARATOR

2 tabs, twice daily

Drug: RANCAD

Interventions

RANCAD DRUG

Extended-Release RANCAD

Also known as: RNTA06

Placebo; RANCAD 1000mg; RANCAD 500mg

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients aged ≥ 20 years old
• A minimum 3-month history of stable angina
• Patients with diagnosis of coronary artery disease (CAD)
• Patients present with the symptoms of stable angina after withdrawn from other antianginal drugs and given the required background therapy for at least 7 days will be qualified for entering this study and performing 1st ETT qualifying test
• Patients developed exercise-induced ECG ischemiai during two qualifying exercise treadmill testsii. The difference between twoiii tests should be ≤ 20% of the longer test or ≤ 1 minute i. Exercise-induced ECG ischemia is defined as the new development of horizontal or down-sloping ST-segment depression of ≥1mm at 60-80ms after the J point; if patients with baseline ST depression at rest (\<1mm), qualifying ST segment depression is defined as additional ST depression of at least 1 mm below the resting value ii. Exercise treadmill test (ETT) will be performed by Modified Bruce Protocol. iii. Two qualifying tests will be conducted 1 week apart, a 3rd ETT test will be performed ≤ 3 days when differences between previous two qualifying ETTs \>20% of the longer test or \>1 minute
• Willing and able to provide a written informed consent

You may not qualify if:

• Factors that might compromise ECG or ETT interpretation
• Patients with resting ST-segment depression ≥ 1mm in any lead
• Left bundle-branch block
• Patients implanted with pacemaker
• Patients under Digitalis therapy
• Patients with family history of (or congenital) long QT syndrome
• Patients with congenital heart disease
• Patients with uncorrected valvular heart disease
• Patients with unstable angina, or MI, or coronary revascularization procedure ≤ 2 months prior enter this study
• Female who is pregnant/lactating or planning to be pregnant, or female of childbearing potential\* who is not using medically recognized method of contraception
• \*Other than those who have been surgically sterilized (defined as having undergone hysterectomy or bilateral oophorectomy or bilateral salpingectomy; tubal ligation alone is not considered sufficient) or one year post-menopausal.
• Patients are under any one of the following conditions:
• New York Heart Association (NYHA) Class III or Class IV congestive heart failure (CHF)
• QTc \> 450 msec at screening
• Active myocarditis, pericarditis, hypertrophic cardiomyopathy

Sponsors & Collaborators

• TSH Biopharm Corporation Limited: lead

Study Sites (6)

Far Eastern Memorial Hospital

New Taipei City, New Taipei city, 220, Taiwan

Location

Mackay Memorial Hospital

Taipei, Taipei City, 104, Taiwan

Location

Shin Kong WuHoSu Memorial Hospital

Taipei, 111, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

Linkou Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Angina, Stable

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Juey-Jen Hwang, M.D., Ph.D.,

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2014
• First Posted: November 19, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 28, 2017

Record last verified: 2017-04

Locations

TW (6)